|Perrigo Receives FDA Tentative Approval For Generic Prandin(R); US and EU Accept PLEGRIDY™|
|By Staff and Wire Reports|
|Friday, 19 July 2013 19:07|
Perrigo Company (Nasdaq: PRGO) announced it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for repaglinide tablets, the generic equivalent to Prandin® Tablets (repaglinide tablets).
Prandin® tablets (repaglinide tablets), are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of approximately $250 million, as measured by Symphony Health Solutions.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval shows the talent and expertise of our R&D and regulatory affairs departments. This is another example of Perrigo's commitment to bring new products to market and deliver on its mission to provide quality, affordable healthcare to consumers."
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Biogen Idec (NASDAQ: BIIB) announced U.S. and EU regulatory authorities have accepted the marketing applications for the review of PLEGRIDY™ (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec's Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States and granted the company a standard review timeline. The Marketing Authorisation Application (MAA) of PLEGRIDY for review in the European Union was also validated by the European Medicines Agency.
The regulatory applications included positive one-year results from the two-year global Phase 3 ADVANCE study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.
“We expect that interferons will remain an important and widely used option for patients with MS. At one-year, PLEGRIDY demonstrated significant reductions in relapses and disability progression, as well as a robust impact on several MRI endpoints,” said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. “PLEGRIDY, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment.”
Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the marketing applications for the review of PLEGRIDY™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS).
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, will announce results for the second quarter ended June 30, 2013 on Monday, August 5, 2013, after market close.
Dr. Reddy's Laboratories (NYSE: RDY) will announce results for the First Quarter ended June 30, 2013 on Tuesday, July 30, 2013 after the Board Meeting.
GTx, Inc. (Nasdaq: GTXI) today provides a Company update and reports financial results for the second quarter of 2013.
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will release financial results for the three and six months ended June 30, 2013, following the close of the market on Monday, July 29, 2013.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced results for the quarter ended June 30, 2013.
There is no bigger stage in the body building and fitness world than "Joe Weider's Olympic Fitness and Performance Expo" and Limitless Venture Group Inc's. (OTC Pink: LVGI) G.E.A.R. sports nutraceuticals subsidiary will be a major player on that stage.
Medistem, Inc. (PINKSHEETS: MEDS) today announced that Alan J. Lewis, Ph.D., the Company's Chief Executive Officer, will host a conference call at 4:30 pm Eastern time (1:30 pm Pacific time) on July 25, 2013.
NanoViricides, Inc. (OTC BB: NNVC), reports that a video interview with its CEO, Eugene Seymour, MD, MPH, was broadcast on the Fox Business News TV channel (FBN TV) today at 1:00am EDT. A link to a video of this interview will be made available on the Company’s website next week.
OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, was featured in a news segment airing July 17 on San Francisco’s ABC affiliate KGO-TV Channel 7.
pSivida Corp. (Nasdaq: PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for the treatment of back-of-the-eye diseases, today announced that it has priced an underwritten public offering of 3,494,550 shares of its common stock at a price to the public of $3.10 per share, for gross proceeds of approximately $10.8 million.
TelVue®Corporation (PINKSHEETS: TEVE), the innovation leader in Television and Internet Broadcasting for media companies, cable operators, and communities has launched The Knowledge Network (tKN) channel.